What happens if the warning on a medicine bottle is in a language you don't understand?
And, what happens if you give it to your baby?
Jorge Ramirez--blind, quadriplegic and mentally impaired--is an example of what happens when manufacturers don't translate drug warnings into language all consumers can understand, according to a lawsuit brought by his family.
In 1986 when he was four months old, Jorge's mother, Rosa Rivera, gave her feverish baby St. Joseph's Aspirin for Children. Although a new label on the bottle included an FDA warning that giving aspirin to children had been linked to the rare but devastating Reye's syndrome, it warned only in English. And Jorge's mother, like many of her Modesto neighbors, speaks and reads only Spanish.
Jorge is 8 now and his case is the center of the hottest debate in years over the rights of American consumers who don't speak English and the obligations of drug manufacturers who aggressively court their business.
At issue, too, is whether a drug maker can be sued for failing to issue warnings in a language other than English.
Last week, four powerful activist legal groups joined a four-year court battle to force the company that made St. Joseph's Aspirin for Children to defend its failure to issue warnings that could be understood by Spanish-speaking buyers.
At simultaneous press conferences in Los Angeles and in Washington announcing their action, lawyers for the ACLU, the Mexican American Legal Defense and Educational Fund, the Public Citizens Health Research Group, and Trial Lawyers for Public Justice called the Ramirez case "a potential landmark in terms of language discrimination."
Drug makers argue that the family's lawsuit would force them to put non-English language warnings on all their products, burdening companies with the job of translating package labels into about 140 languages spoken in the United States. "This has implications for any warning situation--cars, tools, toys, you name it," according Charles Preuss, attorney for the aspirin manufacturer.
For years, the Ramirez family says, they--like many other Spanish-speakers in California--had been faithful users of the Plough Inc.'s St. Joseph's brand.
While the children's aspirin was on the market (it was pulled from shelves in 1986), Plough capitalized on Latino communities' special fondness for the religious-sounding name. According to the Ramirez lawsuit, the company had used Latino media, including Spanish-language radio and Spanish-language advertising in pharmacies, to promote its products.
But the company, which admits it targeted Spanish-speaking consumers, denies any Spanish-language marketing was being done when Jorge was given aspirin. Plough lawyers also question whether it was St. Joseph's aspirin that caused the child's injuries.
When Jorge developed a fever while recovering from a respiratory flu, his mother did what she had done with her five older children when they were sick: She treated the fever with orange-flavored St. Joseph's aspirin.
After two days of treatment, Jorge suffered a seizure and was admitted to a local hospital, diagnosed with Reye's syndrome, a potentially fatal neurological disorder first linked to aspirin in children by a 1981 series of studies by the Centers for Disease Control.
Today, Jorge requires round-the-clock care from his family. "He really can't do anything by himself," says his mother, who says she was unaware of the danger of giving aspirin to her children. The family went to court in hopes that "other children don't have to go through what Jorge has."
From the start, Plough, fought efforts to put warnings on aspirin bottles. As early as January, 1982, the company pressured the American Academy of Pediatrics not to alert the nation's pediatricians about the then-suspected link between aspirin and Reye's syndrome. (In 1986, the FDA mandated warnings on aspirin, agreeing that there was indeed a link.)
Dr. M. Harry Jennison, then the academy's executive director, said three representatives of the drug maker visited him three hours before his newsletter was to go to press. "They wanted to make it very clear that if (the aspirin alert) went out, we would face a very serious lawsuit," Jennison said in a news story in 1987.
Jennison pulled the Reye's item, but sent a special advisory in the following month's newsletter.
Over the next four years, the company--now known as Schering-Plough Corp. --fought federal efforts to require warning labels, working with the Aspirin Foundation of America to lobby their case.
Between 1982 and 1986, when the FDA mandated the warnings, there were 730 cases of aspirin-caused Reye's syndrome reported to the federal Centers for Disease Control and Prevention. But public health experts estimated the true incidence of the syndrome might have been three to eight times higher.
Many of the victims, said Dr. Sidney Wolfe of Public Citizen's Health Research Group, were children of English-speaking parents who "would be healthy today if warning labels had started in 1982." But for Spanish-speaking parents like Jorge's, charged Wolfe, "the slaughter may still be continuing."
The New Jersey-based Plough company stopped making St. Joseph's Aspirin for Children in December, 1986. The firm said sales plummeted when it became widely known that Reye's syndrome could strike children who took aspirin for chicken pox or flu.
The FDA requires only English-language labels on foods and drugs sold in the United States and has taken no position on the Ramirez case. The exception is Puerto Rico, where the predominant language is Spanish. If manufacturers do elect bilingual labeling, the FDA requires full-text translations.
Along the Mexico-California border, family-owned pharmacies often stock drug and beauty products manufactured for sale in Mexico--products with full-text Spanish labels and warnings. Even some of the larger chain stores, such as Sav-On and Thrifty, carry cough medicines, sun creams and a handful of other items with Spanish-English labeling.
California's Proposition 63 sought to make English the state's official language by requiring the Legislature and state government to "ensure that the role of English as the common language . . . is preserved and enhanced."
Although the measure was added to the state Constitution in 1986, it has not discouraged bilingualism in school systems and other areas of California life. And court cases in this and other states have found that the public safety might sometimes require the use of symbols or language to warn against dangers.
A jury found in a 1985 case that a pesticide manufacturer had a legal responsibility to warn migrant workers using the toxic chemical about the dangers it posed. Although the workers spoke no English, the court ruled they could have been--and should have been warned with easy-to-understand symbols showing that the pesticide was poisonous.
The Ramirez family lost their first court battle in March, 1991, when a Stanislaus County judge ruled there were no grounds for their case to go to trial. But the parents appealed to the Fifth District Court in Fresno and won, opening the way for the case to go to the California Supreme Court later this year.
But whether a manufacturer which markets its products in California--even if it markets them in another language--has the responsibility to label those products in that language is a question to be decided by a jury. The state Supreme Court will decide if the Ramirez case can go to a jury.
A spokesman for Schering-Plough said last week that the company believes "appropriate warnings in English are sufficient and manufacturers should not have to provide warnings in all of the 143 or more languages spoken by potential U.S. consumers."
The company claims that requiring foreign language warnings "would impose a potentially unreasonable burden." In court, the company has maintained that no Spanish-language marketing was being done when Jorge Ramirez was given the aspirin. The company also disputes whether its brand of aspirin was given to the child and whether aspirin of any kind was the true cause of the child's quadriplegia, blindness and mental retardation.
But lawyers for the ACLU and other consumer groups who have joined the lawsuit against Plough charge that the drug industry is exaggerating the impact of the case. A victory for the Ramirez family, they say, would only require companies to prove in particular cases that English-only warnings are sufficient.
"All consumers have the right to make informed buying decisions," said Dianna Lyons of Trial Lawyers for Public Justice. "Plough denied Jorge Ramirez's mother that right. Now her little boy is suffering severe disabilities--a tragedy Plough could have prevented by providing a warning that his mother could understand."